Impact of Exercise Training on Single Ventricle Function in Paediatric Fontan Patients

Univentricular Heart Clinical Trial

Official title:

A Single-centre, Prospective Case Control Study Evaluating the Impact of a Standardised Aerobic and Strength Exercise Regime on Exercise Capacity, Ventricular Function, and Perceived Quality of Life in Paediatric Fontan Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05617534
• Other study ID #: RSFG-21-ACC13
• Status: Not yet recruiting
• Start date: January 10, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: Children's Health Ireland at Crumlin
• Contact: Li Yen Ng, MB BCh BAO
• Phone: +353862341835
• Email: ngliyen[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to learn about how a prescribed Exercise Training Program would affect children living with a Fontan circulation.

From birth, the children who are born with single functioning ventricle will undergo 3-staged Fontan surgery to achieve a unique Fontan circulation, supported by one functioning ventricle. With advancement in surgical technique and medical care, there are increasing number of children living with Fontan circulating surviving into adulthood.

A significant number of these individuals develop complications in their adulthood due to problems related to this unique circulation, including reduced exercise tolerance, heart failure, abnormal heart rhythm or premature death. Many of these children have acquired sedentary lifestyle, and may have lower self-perceived health related quality of life.

Exercise training is a well-established therapy used in adult population with heart failure. It has been shown to be safe in children with congenital heart disease and with Fontan circulation, it improves their aerobic exercise capacity which is associated with better outcomes.

The main question[s] it aims to answer are the impact of a Exercise Training program on:

1. Single ventricle function

2. Exercise capacity

3. Self-perceived quality of life

4. Skeletal muscle mass

Participants will be given a 20-weeks exercise program, 3 sessions of 30 minutes workout weekly, to carry out at home. The following tests will be performed prior to starting and upon completion of the exercise program:

• Echocardiogram

• Cardiopulmonary exercise test

• Body composition scan using a bio-impedance analyser

• Quality of life questionnaires

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• Patients with Fontan circulation, age range 8 to 18 years

• Ability to perform a cardiopulmonary exercise stress test (CPET)

• Free from acute or chronic respiratory illness and/or conditions that might affect exercise performance

• Who have had a Fontan operation at least six months prior.

Exclusion Criteria:

• Existing neuro-disability i.e. with paresis post cerebrovascular accident

• Neurodevelopmental issue with inability to comply with commands.

• Documented life-threatening arrhythmia without implantable cardioverter defibrillator

• Moderate or severe atrio-ventricular valve regurgitation

• Moderate or severe ventricular dysfunction by echocardiography exams

• Acute inflammatory cardiac disease

• documented coronary artery stenosis and/or myocardial ischaemia

• Heart failure requiring hospitalisation in the past year

• Evidence of systemic venous pathway obstruction by echocardiography or catheterisation

• Resting oxygen saturation < 90%

• Systemic ventricular outflow tract stenosis with peak resting systolic gradient > 50mmHg

Related Conditions & MeSH terms

• Univentricular Heart

Locations

Country	Name	City	State
Ireland	Children's Health Ireland	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
Children's Health Ireland at Crumlin	CHI Research & Innovation Office

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Single ventricle Function	By implementing a prescribed exercise training regime over a 20 week period, a change will be noted in ventricular function at the subclinical state using Echocardiography parameters.	After a 20 week Exercise training program
Secondary	Exercise Capacity	By implementing a prescribed exercise training regime over a 20 week period, an improvement will be noted in functional exercise capacity, which will be objectively assessed using cardiopulmonary exercise test.	After a 20 week Exercise training program
Secondary	Self-perceived Quality of life - Generic	By implementing a prescribed exercise training regime over a 20 week period, an improvement will be noted in self-reported quality of life, which will be assessed using validated QOL questionnaire - Using Paediatric Quality of Life Inventory, PedsQL v4.0	After a 20 week Exercise training program
Secondary	Self-perceived Quality of life - Cardiac module	By implementing a prescribed exercise training regime over a 20 week period, an improvement will be noted in self-reported quality of life, which will be assessed using validated QOL questionnaire - Using PedsQL Cardiac Module v3.0	After a 20 week Exercise training program
Secondary	Skeletal muscle mass	By implementing a prescribed exercise training regime over a 20 week period, an improvement will be noted in the skeletal muscle mass, which will be assessed using a non-invasive bio-impedance analyser.	After a 20 week Exercise training program